As stated in 21 CFR Part 58 Subpart A58.1(a), Nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. Compliance with this part is intended to assure the quality and integrity of the safety data filed. Procedures for regulated studies follow GLP guidelines.